1.0 Policy Purpose
The purpose of this policy is to define the requirements to serve as a Principal Investigator (PI) of a Brown Animal Care and Use Committee (IACUC) protocol and the associated responsibilities of the PI.
2.0 To Whom the Policy Applies
This policy applies to all individuals who will be listed as PI on a Brown University IACUC approved animal use protocol.
3.0 Policy Statement
Except as otherwise approved as described below in order to serve as the PI on a Brown IACUC animal use protocol, the individual must have an employment relationship and/or affiliation with Brown University that satisfies one of the following conditions:
- Be employed by the University as a faculty member (all ranks), including “research” faculty;
- Be employed by a Brown-affiliated institution, hold an appointment, and require use of an animal care facility, under the Center for Animal Resources and Education’s (“CARE’s”) oversight, for the proposed animal work;
- Be employed as a veterinarian in the CARE; or
- Be employed at an entity that has an approved contract with Brown University to use the animal research facilities.
Adjunct faculty and postdocs will be considered on a case-by-case basis, upon written request to the IACUC, and with written permission from the individual’s cognizant Dean or supervisor.
Additionally, the Vice President for Research may, on a case-by-case basis, approve other qualified individuals to serve as a PI regardless of employment relationship and/or affiliation with Brown University.
Students (undergraduate and graduate) may not serve as PIs. They may be listed as study personnel.
The Brown IACUC does not require that the PI of an IACUC protocol be the PI of funding sources cited on the protocol. For example, if a National Institutes of Health (NIH) award is funding, in whole or in part, the activities on an IACUC animal use protocol, the PI of the IACUC animal use protocol is not required to be the PI of the NIH grant.
3.1 Protocol Oversight
The PI must ensure that all members of the research team have access to any IACUC- approved animal use protocol on which they are listed as personnel, that all personnel have read and understood the IACUC protocol, and that work does not commence until IACUC approval is received. In addition, the PI is responsible for ensuring that the IACUC protocol is amended as needed, and that a de novo protocol is submitted when work extends beyond three years from the protocol’s original IACUC approval date. The PI is expected to adhere to veterinary pre-consultation requirements when writing the animal use protocol, and must meet all protocol review-related deadlines.
3.2 Training Oversight
The PI must ensure that all personnel listed on the IACUC protocol comply with the IACUC Directive 4.0: Training and Education of Personnel Working with Laboratory Animals. The PI must complete all of the “Required Core Training” outlined in the Training Directive, as well as any additional training that applies to work the PI will perform or directly supervise on the project.
3.3 Reporting Adverse Events, Non-compliance, and Animal Welfare Concerns
In accordance with the IACUC Directive 16.0: Prompt Reporting, the PI must promptly report to the IACUC any adverse events, non-compliance incidents, and animal welfare concerns that occur under the IACUC-approved animal use protocol. The PI must cooperate with any investigations of such incidents conducted by internal University personnel or by external regulatory agencies and must implement or assist with implementing any recommendations resulting from such investigations. If the IACUC requests corrective actions, the PI must ensure that corrective actions are implemented timely and that study personnel participate in any required re-training. When non-compliance incidents involve external reporting (i.e., to the U.S. Department of Agriculture (USDA), Office of Laboratory Animal Welfare (OLAW), a study sponsor, or accrediting body), the PI will be given the opportunity to review the IACUC’s draft report to the external body and must respond to the IACUC within 24 hours with any factual corrections.
3.4 Participation in Routine and For-Cause Inspections
PIs are responsible for ensuring their laboratory space(s) and associated personnel are available for routine IACUC semi-annual facility inspections and for cause inspections. While it is preferred that the PI be present for inspections and available to meet with inspectors whenever feasible, the PI may delegate a responsible party within the laboratory who is intimately familiar with the IACUC animal use protocol(s) and the day-to-day work of the lab to be present and available in the PI’s place. The PI must ensure that any inspection findings are rectified by the assigned date for correction.
External regulatory and accrediting bodies, such as the USDA and AAALAC, routinely inspect Brown’s animal care facilities and animal laboratory spaces. When the PI is required to be present for inspections by regulatory or accrediting bodies, the PI will grant reasonable access to enable inspection, and promptly, accurately, and professionally respond to inspector queries.
3.5 Transfer of PI and/or Delegation of an Alternate PI
Transfer of an IACUC-approved animal use protocol to a new PI is considered a significant modification that requires an amendment to the protocol and approval by the IACUC. If the PI of an IACUC-approved animal use protocol will not be physically present at Brown or at a Brown-affiliated institution (as applicable) for six months or more, the PI must delegate a qualified alternate PI on the animal use protocol or make arrangements to provide day-to-day oversight of the laboratory’s animal research program.
The alternate PI must meet the PI eligibility criteria of this Policy and assume the associated responsibilities of the PI for the duration of the PI’s absence. The alternate PI delegation request must be submitted as an amendment to the IACUC-approved protocol for the IACUC’s review and consideration sufficiently in advance of the PI’s expected absence to ensure that approval is received before the PI’s departure.
4.0 Definitions
For the purpose of this policy, the terms below have the following definitions:
- Principal Investigator (PI):
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The person “responsible for a proposal to conduct research and for the design and implementation of research involving animals.” (9 C.F.R. § 1.1 (Definition of “Principal Investigator”)). The PI is responsible for the design and implementation of a protocol detailing research, testing or teaching using Live-Vertebrate Animals, as well as for all work involving animals under that protocol. The PI ensures that all work and personnel on the PI’s protocol is compliant with all applicable federal, state, and institutional requirements.
5.0 Responsibilities
All individuals to whom this policy applies are responsible for becoming familiar with and following this policy. University supervisors and employees with student oversight duties are responsible for promoting the understanding of this policy and for taking appropriate steps to help ensure and enforce compliance with it.
6.0 Consequences for Violating this Policy
Violation of this policy may be considered a serious event of noncompliance that is reportable to the IACUC, funding and accrediting agencies, as well as other regulatory agencies. Violation of this policy is a serious matter that may adversely affect both the ability to perform animal work and acquire funding sources.
Failure to comply with this and related policies, directives, and SOPs is subject to disciplinary action, up to and including suspension without pay, or termination of employment or association with the University, in accordance with applicable (e.g., staff, faculty, student) disciplinary procedures.
7.0 Related Information
Brown University is a community in which individuals are encouraged to share concerns with University leadership. Additionally, Brown's Anonymous Reporting Hotline allows anonymous and confidential reporting on matters of concern online or by phone (877-318-9184).
The following information complements and supplements this document. The information is intended to help explain this policy and is not an all-inclusive list of policies, directives, procedures, laws and requirements.
7.1 Related Policies:
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7.2 Related Procedures:
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7.3 Related Forms:
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7.4 Frequently Asked Questions (FAQs):
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7.5 Other Related Information:
- Directive 4.0: Training and Education for Personnel Working with Laboratory Animals
- Directive 16.0: Prompt Reporting
- Guide for the Care and Use of Laboratory Animals, Eighth Edition
- The Public Health Service Policy on Humane Care and Use of Laboratory Animals, Office of Laboratory Animals
- Animal Welfare Act
- United States Department of Agriculture Animal and Plant Health Inspection Service
Policy Owner and Contact(s)
Policy Owner: Vice President for Research
Policy Approved by: Vice President for Research
Contact Information:
Policy History
Policy Issue Date:
Policy Effective Date:
Policy Update/Review Summary:
This policy was reviewed and approved at the April 10, 2026, IACUC meeting.
Previous policy version(s) superseded by this policy:
- IACUC: Policy on Principal Investigator Eligibility & Responsibilities, Effective Date: December 1, 2020, Rescinded: July 5, 2023
- IACUC Policy Principal Investigator Eligibility & Responsibilities, date of IACUC review and approval: June 2, 2017